Skip to content

da Vinci SP Robotic Gastrectomy

The Safety and Feasibility of Reduced Port Robotic Distal Gastrectomy Using da Vinci SP for Early Gastric Cancer

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05051670
Enrollment
19
Registered
2021-09-21
Start date
2021-12-16
Completion date
2022-12-11
Last updated
2023-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Cancer

Keywords

da vinci SP, robotic surgery, gastrectomy, gastric cancer

Brief summary

Laparoscopic surgery revolutionized the surgical treatment of gastric cancer saving large incsion and associated pain. Robotic surgical system was introduced to enhance the minimally invasive surgery using articulating robotic arm. The da vinci SP system, which enables single-port surgery, can allow surgeon to provide radical gastrectomy with minimal scar and associated pain.

Detailed description

This study is a phase 1/2, single-arm surgical clinical trial. The primary endpoint is the safety of da vinci robotic gastrectomy. The secondary endpoint is operative time, bleeding, bowel recovery, and hospital stay. In the clinic, informed consent is received from patient who is scheduled to undergo radical gastrectomy. After the general anesthesia, low midline transverse incision is made at suprapubic area. After inserting SP port into the peritoneal cavity, additional port is inserted via right flank that would be used for assistant's energy device and suction devices. Radical subtotal gastrectomy is perfromed using cardiere-forceps, monopolar scissors, and maryland forceps. Reconstruction after gastrectomy is decided according to surgeon's preference. three days after gastrectomy, if the diet build up is complete and the patients has no evidence of complication, the patient is discharged from the hospital. Four weeks after gastrectomy, the patient will be followed up at the clinic. Major complication event within 30days after gastrectomy will be analyzed as primary endpoint as well as other secondary endpoints.

Interventions

PROCEDUREda vinc SP gastrectomy

radical subtotal gastrectomy performed by da vinci SP

Sponsors

Yonsei University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* Biopsy confirmed adenocarcinoma of stomach scheduled to undergo radical gastrectomy * Between 20-80 * ASA score (American society of anesthesiology) class: I - III * Signed to informed consent after through explanation about the study

Exclusion criteria

* distant metastasis * EMR/ESD canddiate * complicated gastric cancer (obstruction or perforation) * Active other primary tumor * Vulerable subject (illiterate, pregnant)

Design outcomes

Primary

MeasureTime frameDescription
major complication30 days after gastrectomyClavien-Dindo classification grade 3 or more

Secondary

MeasureTime frameDescription
Operation time30 days after gastrectomyduation of operation in minutes
bleeding30 days after gastrectomyamount of bleeding shed during the operation in ml
bowel recovery30 days after gastrectomygas passing day after the surgery
Hospital stay30 days after gastrectomydays between the opeation day to discharge day

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026